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CTRI Number  CTRI/2022/07/043632 [Registered on: 01/07/2022] Trial Registered Prospectively
Last Modified On: 24/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Parasurgical]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Non surgical Management of Hemorrhoid 
Scientific Title of Study   Study of efficacy of Kadali Kshar Pratisaran in the management of Abhyantar Arsha W.S.R. to Internal Haemorrhoids 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amit Ashok Paliwal 
Designation  Assistant Professor Department of Shalyatantra  
Affiliation  Bharati Vidyapeeth (Deemed to be University) College of Ayurved Pune  
Address  Department of Shalyatantra Bharati Vidyapeeth (Deemed to be University) College of Ayurved Satara road Pune

Pune
MAHARASHTRA
411043
India 
Phone  9960921773  
Fax    
Email  amit.paliwal@bharatividyapeeth.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Vasudha Asutkar 
Designation  Assistant professor  
Affiliation  Bharati Vidyapeeth (Deemed to be University) College of Ayurved Satara road Pune 
Address  Department of Samhita evum Siddhant, Bharati Vidyapeeth (Deemed to be University) College of Ayurved Satara road Pune

Pune
MAHARASHTRA
411043
India 
Phone  8087975264  
Fax    
Email  vasudha.asutkar@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Dr Amit Ashok Paliwal 
Designation  Assistant professor  
Affiliation  Bharati Vidyapeeth (Deemed to be University) College of Ayurved Satara road Pune 
Address  Room no. 3, Department of Shalyatantra, Bharati Vidyapeeth (Deemed to be University) College of Ayurved Satara road Pune

Pune
MAHARASHTRA
411043
India 
Phone  9960921773  
Fax    
Email  amit.paliwal@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth College of Ayurved Pune  
 
Primary Sponsor  
Name  Bharati Vidyapeeth Deemed to be University Pune 
Address  Sadashiv peth,Pune 30 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amit Paliwal   Bharati Vidyapeeth (Deemed to be University) College of Ayurved Pune   Department of Shalyatantra Bharati Vidyapeeth (Deemed to be University) College of Ayurved Satara road Pune
Pune
MAHARASHTRA 		 9960921773

amit.paliwal@bharatividyapeeth.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kShArakarma, क्षारकर्म (Procedure Reference: Sushruta samhita, Procedure details: In lithotomy position, kadali kshara will be applied over hemorrhoid with the help of applicator for Vaakshatamatra under Local anaesthesia. Then kshara will be washed with Kanji. ))
(1) Medicine Name: Triphala Guggulu , Reference: Sharangadhara samhita madhyam khanda, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 7 Days
(2) Medicine Name: Gandharva Haritaki , Reference: Bhavaprakasha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: hs, Duration: 14 Days
2Comparator Arm (Non Ayurveda)-Inj SetrolIn Lithotomy position, inj Setrol 0.5ml diluted in 0.5ml Distilled water and injected submucosal in each hemorrhoid under local anaesthesia.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Diagnosed patient patient of Abhyantara Arsha with I, II and III degree.
2.Patient in age group of 18-70 years.
3.Patient with controlled systemic diseases like Diabetes and Hypertension. 
 
ExclusionCriteria 
Details  1.Abhyantara Arsha of secondary origin and/or associated pathology of colon and anal canal.
2.Patients having Hb% less than 8gm%.
3.Patient associated with uncontrolled systemic diseases like Diabetes and Hypertension.
4.Pregnant women.
5.Patients with infective conditions like HIV and HbsAg. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Kadali kshara pratisarana is effective in Reduction in size of Abhyantara Arshas  21 days study with followup on 4th, 7th, 14th and 21st day. 
 
Secondary Outcome  
Outcome  TimePoints 
Kadali kshara karma procedure is useful to control the per rectal bleeding.  21days study with followup on 1st, 4th, 7th, 4th and 21st day. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   04/07/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Study the efficacy of Kadali kshar Pratisaran on 30 patients comparing with rest 30 patients suffering with the Abhyantara Arsha W.S.R. to Internal Haemorrhoids. Procedure will be done in lithotomy Procedure and under local anaesthesia. Post procedure patient will be given Gandharva Haritaki 1gm HS for 14days, Triphala Guggulu Twice a day for 7days, Avagaha sweda for 7days. 
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